Abstract: A transcutaneous prosthesis includes a first component shaped for implantation into a bone, the first component including flutes or grooves on a surface thereof for deterring rotation of the prosthesis within a bone; a second component adapted for location between the bone and the skin, the second component having a surface treatment for stimulation of fibroblastic cell proliferation and attachment of epithelial cells; and a third component adapted for location to extend from the skin surface and is adapted to extend directly from the skin surface in use, the third component having a coating of a non-stick material on an outer surface thereof, the coating having a surface energy that is lower than a surface energy of the first and second components and which is low enough to deter bacterial adhesion.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Abstract: The present disclosure provides nerve interface devices, such as passive or active nerve caps or regenerative peripheral nerve interface devices (RPNI), for a subject in need thereof. The nerve interface devices include nerve interface cap devices capable of treating, minimizing, or preventing formation of neuromas in severed or damaged nerve endings. Such a nerve interface device includes a housing that may be formed of a scaffold, such as a biotic material or hydrogel, an autograft, and optionally an electrode and/or conducting polymer. The autograft may be free muscle or free skin tissue, which is attached to the nerve ending to permit reinnervation. The present disclosure also provides methods for treating, minimizing, or preventing neuroma formation in a subject having a severed or damaged nerve, especially a peripheral nerve.

Abstract: A monolithic material including a first region having a first variability of strength and a second region joined to the first region, the second region having a second variability of strength, wherein the monolithic material has a variability of strength less than the first variability of strength of the first region and less than the second variability of strength of the second region.

Abstract: The present invention relates to a novel bone graft and methods for producing said graft. Said bone graft can be used for surgical, plastic and/or cosmetic bone replacement for a patient in need thereof. The bone graft is made of a scaffold or matrix of sheet material having a 3-dimensional pattern of a continuous network of voids and/or indentations for enhancing new bone growth.

Abstract: A system and method for the repair of damaged tissue and bones, congenitally missing tissue/cosmetic reconstruction of tissue is described. The system has a layered porous structure with a sufficiently large area of exposed pores to promote neo-vascularization as well as bone and tissue formation. The disclosed porous implant system can contain bioactive agents necessary for rapid tissue formation and keep ingrowth of unwanted tissue out of the implant surgical site. The implant can be reinforced with an additional, stronger polymer layer and/or may include an endoskeleton or exoskeleton for dimensional stability.

Abstract: Implantable biomaterials, particularly hydrogel substrates with porous surfaces, and methods for enhancing the compatibility of biomaterials with living tissue, and for causing physical attachment between biomaterials and living tissues are provided. Also provided are implants suitable for load-bearing surfaces in hard tissue repair, replacement, or augmentation, and to methods of their use. One embodiment of the invention relates to an implantable spinal disc prosthesis.

Abstract: Provided herein is a biocompatible implant for meniscus tissue engineering. Particularly, the biocompatible implant comprises a multi-layered crescent-shaped silk fibroin scaffold, in which each layer comprises distinct pore size and/or pore orientation, e.g., to mimic native meniscus complex architecture. Accordingly, the biocompatible implant can be used for repairing any meniscal defect or promoting meniscal regeneration in a subject.

Abstract: A medical device for implantation into vessels or luminal structures within the body is provided, which stimulates positive blood vessel remodeling. The medical device, such as a stent and a synthetic graft, is coated with a pharmaceutical composition consisting of a controlled-release matrix and one or more pharmaceutical substances for direct delivery of drugs to surrounding tissues. The coating on the medical device further comprises a ligand such as a peptide, an antibody or a small molecule for capturing progenitor endothelial cells in the blood contacting surface of the device for restoring an endothelium at the site of injury. In particular, the drug-coated stents are for use, for example, in balloon angioplasty procedures for preventing or inhibiting restenosis.

Abstract: The invention relates to implantable collagen devices made by seeding at least one elongate collagen construct, e.g., comprising at least one elongate synthetic collagen fiber with a plurality of cells and applying a strain and/or stress to the at least one elongate collagen fiber to induce the cells to differentiate into target phenotypes, e.g., tendon or ligament phenotype cells (and/or fibroblasts), typically with an extracellular matrix of collagen to organize into a tissue on the at least one collagen fiber.

Abstract: An implant device for humans or mammals has a body structure having an exposed surface and one or more selected portions of the exposed surface having a bone formation enhancing 3-dimensional pattern. The exposed surface can be on exterior portions of the body structure or internal portions of the body structure or both. The one or more selected portions of the exposed portions having the bone formation enhancing 3-dimensional patterns are in the external exposed surfaces or in the internal exposed surfaces or both internal and external exposed surfaces.

Abstract: The invention relates to a biocompatible neural implant for bridging interruptions or defects in nerves resulting from injuries sustained in an accident or following surgery. Inventive neural implants comprise fibers made from natural or synthetic spider silk and allow interrupted nerves to regenerate across defects such that functional nerve conduction is made possible within a short period of time.

Abstract: A transvesicular drainage device configured to drain excess fluid from a variety of locations in the human body into the bladder. The device may be used to treat ascites or any fluid collection within the body of a human or of a non-human mammal.

Abstract: A surgical implant is provided which includes a body and a coating in contact with at least a portion of the body, the body including metallic magnesium, the coating including a hydrogel having an adhesion peptide contained therein. The adhesion peptide may be derived from an extracellular matrix protein and may be covalently bonded to the hydrogel. A method of making a surgical implant includes providing a magnesium based degradable implant body; applying and adhering a functionalized reactive silane based adhesion promoting layer to the implant body; providing a hydrogel monomeric solution having extracellular matrix adhesion peptides incorporated therein; and contacting the hydrogel monomeric solution with the adhesion promoting layer such that the hydrogel polymerizes and bonds to the adhesion promoting layer and encapsulates at least a portion of the implant.

Abstract: A surgical implant comprising: a substrate having an exterior surface and a plurality of layers disposed over the substrate exterior surface. The substrate comprises a polymeric material, and the plurality of layers comprises: an activated substrate surface layer; a valve metal layer; and a porous valve metal oxide layer, wherein the valve metal layer is disposed between the activated substrate layer and the porous valve metal oxide layer. The disclosure provides for a method for producing a polymeric surgical implant. The exterior substrate surface is treated by one or more processes comprising: plasma activation; electron beam irradiation; ultraviolet light; and low energy Ar+ ion beam irradiation; producing an activated substrate surface layer. A plurality of layers is applied over the activated substrate surface layer. The surface is converted by a spark-anodization process in an alkaline bath containing Ca and P ions into a layer of porous valve metal oxide.

Abstract: One embodiment of the implant comprises a porous metal bone ingrowth portion (14) having a first side connected to a high density or solid (fully dense) metal portion (16) which in turn has an opposite side connected to a porous metal soft tissue ingrowth portion (12) thus forming a sandwich structure with the high density or fully dense portion in the middle. The implant may be made of a resorbable material such as an alloy of magnesium. Alternately, the alloy can be selected from the group consisting of calcium, iron, yttrium and lithium. The porous metal soft tissue ingrowth portion (12) has porosity characteristics allowing cartilage to interdigitate with the pores and extend outwardly beyond the platform of the metal surface towards a joint capsule. The solid or fully dense intermediate layer 16 may have some porosity, however that porosity prevents either bone tissue or cartilage tissue from migrating therethrough.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Abstract: This invention is directed to graft materials for implanting, transplanting, replacing, or repairing a part of a patient and to methods of making the graft materials. The present invention is also directed to stent grafts and endoluminal prostheses formed of the graft materials. More specifically, the present invention is a graft material which includes porous polymeric sheet, extracellular matrix material (ECM) disposed on at least a portion of the porous polymeric sheet and at least one polymer layer disposed on at least a portion of the ECM. The ECM may be in a gel form. The polymeric sheet and the polymer layer may be made from foam material and may comprise a polyurethane urea and a surface modifying agent such as siloxane.

Abstract: A synovial joint implantable apparatus for the reconstruction of skeletal defects with a flexible member, which is preferably resorbable, attached to a rigid structural prosthesis such as a total hip or total knee replacement implant. The cavitary space defined and surrounded by the flexible member is filled with osteoconductive and/or inductive materials which eventually matures into new column of bone. The prosthesis is supported by the bed of graft material surrounding it and is gradually unloaded as the bed matures into solid bone. The fixation of the prosthesis into native bone depends on the specific implant and the anatomic area of its use. The flexible member is secured to the margins of the prosthesis using rails, runners, sutures, or other attachment devices that prevent the escape of the bone graft and maintain an initial column of support for the implant.

Abstract: The present invention provides selectively laser sintered porous polymeric articles and methods of making and using the same. In one embodiment, a method of the present invention comprises providing a first layer of particles of a first polymeric material, heating selected locations of the first layer to sinter particles of the first polymeric material to form a three-dimensional article, the three-dimensional article having a porosity of at least about 30 percent.

Abstract: A method of installing a transcutaneous prosthesis which includes a first component, a second component adapted for location between the bone and the skin, the second component having a surface treatment for stimulation of fibroblastic cell proliferation and attachment of epithelial cells and a third component adapted for location to extend from the skin surface and the third component having an outer surface. The outer surface of the third component has a surface energy that is lower than a surface energy of at least the first component and which is low enough to deter bacterial adhesion. The method includes attaching the first component to a bone such that a transition from the second component to the third component is essentially at the surface of the skin and the third component extends from the skin surface when the first component is attached to a bone.

Abstract: A method of treating a ligament or tendon according to the present invention can include inserting a tissue-generating implant into the ligament or tendon to thereby treat the defect. The tissue-generating implant has a plurality of microparticles. The microparticles subsequently form a biological scaffold which operates at least as partial connective tissue in the ligament or tendon giving structural support during regrowth.

Abstract: A membrane for implantation in soft tissue comprising a first domain that supports tissue ingrowth, disrupts contractile forces typically found in a foreign body response, encourages vascularity, and interferes with barrier cell layer formation, and a second domain that is resistant to cellular attachment, is impermeable to cells and cell processes, and allows the passage of analytes. The membrane allows for long-term analyte transport in vivo and is suitable for use as a biointerface for implantable analyte sensors, cell transplantation devices, drug delivery devices, and/or electrical signal delivering or measuring devices. The membrane architecture, including cavity size, depth, and interconnectivity, provide long-term robust functionality of the membrane in vivo.

Abstract: The present invention provides hydrogel coated, implantable medical devices and methods of coating hydrogels onto implantable medical devices. In one embodiment, a hydrogel coated medical device is formed by physically treating a surface of the medical device, chemically treating the surface, applying a hydrogel precursor and then crosslinking the hydrogel precursor to form a hydrogel coating on the surface of the medical device. The present invention may be particularly applicable for coating articulating surfaces on implantable medical devices such as artificial joints.

Abstract: A medical device comprises a tubular body having a lumen and a long axis; and a plurality of silk elements laid substantially parallel along the long axis of the lumen of the tubular body. A method of manufacturing the medical device comprises forming the tubular body and introducing the silk elements into the lumen of the tubular body so as to lie substantially parallel along the long axis of the lumen of the tubular body. The device can be used in a method for the regeneration of nerve cells comprising the implantation of a medical device at a site for regeneration of nerves.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Abstract: The present invention relates to artificial tissue growth guides comprising a core and an outer sleeve, which facilitates the regeneration of damaged tissues, such as nerves. The core is fixed to the sleeve at two attachment sites so that cells seeded within the core produce mechanical tension between the attachment sites. This tension aligns the cells and the fibres of the core and provides an improved substrate for tissue regeneration. Growth guides may be surgically implanted into an individual.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Abstract: Implantable biomaterials, particularly hydrogel substrates with porous surfaces, and methods for enhancing the compatibility of biomaterials with living tissue, and for causing physical attachment between biomaterials and living tissues are provided. Also provided are implants suitable for load-bearing surfaces in hard tissue repair, replacement, or augmentation, and to methods of their use. One embodiment of the invention relates to an implantable spinal disc prosthesis.

Abstract: Described, in certain aspects, are medical devices that can be used to anchor graft materials to bodily structures. These devices comprise an implantable graft structure and tissue ingrowth material. This implantable graft structure is comprised of a body of persistent material having a first face and one or more openings defined therein, wherein the persistent material body first face is configured for opposing a bodily structure wall upon implantation. This tissue ingrowth material is positioned at the one or more persistent material body openings, and is configured for receiving tissue ingrowth from the bodily structure wall effective to anchor the graft structure to the bodily structure wall. The invention also provides methods utilizing these and other inventive medical devices, for example, to anchor graft materials to vascular vessel walls and/or other bodily structures.

Abstract: An improved, polymeric surgical membrane, which can be used in a variety of surgical procedures, such as sutured and sutureless duraplasty procedures. For sutureless applications, a textured, discontinuous, outer polymer layer is provided which encourages rapid incorporation and anchoring into surrounding tissue. In cooperation with the discontinuous first layer, a second elastomeric layer provides elasticity and resilience. A third barrier layer is provided to essentially eliminate adhesions and irritation to surrounding tissue. In those applications requiring anchoring sutures, the second elastomeric layer “self-seals” against the sutures, essentially eliminating the leakage of blood, cerebrospinal fluid, or other fluids. In addition, the composite structure of the present invention has a high degree of suture retention strength is polymeric with a high degree of biocompatibility, is thin and very flexible.

Abstract: An implantable device for facilitating the healing of voids in bone, cartilage and soft tissue is disclosed. A preferred embodiment includes a cartilage region comprising a polyelectrolytic complex joined with a subchondral bone region. The cartilage region, of this embodiment, enhances the environment for chondrocytes to grow articular cartilage; while the subchondral bone region enhances the environment for cells which migrate into that region's macrostructure and which differentiate into osteoblasts. A hydrophobic barrier exists between the regions, of this embodiment. In one embodiment, the polyelectrolytic complex transforms to hydrogel, following the implant procedure.

Abstract: A coil device is provided with a stretch resistant feature. The device includes a wound coil defining a lumen and a stretch resistant member at least partially received within the lumen. A restrictor member is also at least partially received within the lumen and defines an aperture adapted to movably receive a portion of the stretch resistant member to allow the wound coil to stretch and elongate. The stretch resistant member includes an enlarged portion that is larger than the aperture and adapted to engage the restrictor member to prevent or resist stretching of the wound coil. The restrictor member may be provided as a separate element fixedly secured to the coil wire, or the coil wire may include one or more minor turns adapted to perform the function of the restrictor member.

Abstract: Compositions and methods are provided for preparing a metal substrate having a uniform textured surface with a plurality of indentations with a diameter in the nanometer and micrometer range. The textured surface is produced by exposing the substrate to an etching fluid comprising a hydrogen halide acid and/or an oxyacid, a chloride containing compound, and an oxidizing agent. The etching solution can be used at ambient temperature without damaging the metal elements on the substrate surface. This textured surface enhances adherence of coatings or cells onto the textured surface, improves the retention of proteins on the surface, and encourages bone in-growth.

Abstract: A coil device is provided with a stretch resistant feature. The device includes a wound coil defining a lumen and a stretch resistant member at least partially received within the lumen. A headpiece is formed by a joining of the coil and a restrictor member, typically by plasma welding. The restrictor member is also at least partially received within the lumen and defines an aperture adapted to movably receive a portion of the stretch resistant member to allow the wound coil to stretch and elongate. The stretch resistant member includes an enlarged portion that is larger than the aperture and adapted to engage the restrictor member to prevent or resist stretching of the wound coil. The restrictor member may be provided as a separate element fixedly secured to the coil wire, or the coil wire may include one or more minor turns adapted to perform the function of the restrictor member.

Abstract: A composite material for positioning in the anatomy to form a selected function therein. The composite may be resorbable over a selected period of time. The composite may allow for selected bone ingrowth as absorption of the composite occurs.

Abstract: A biointerface membrane for an implantable device including a nonresorbable solid portion with a plurality of interconnected cavities therein adapted to support tissue ingrowth in vivo, and a bioactive agent incorporated into the biointerface membrane and adapted to modify the tissue response is provided. The bioactive agents can be chosen to induce vascularization and/or prevent barrier cell layer formation in vivo, and are advantageous when used with implantable devices wherein solutes are transported across the device-tissue interface.

Abstract: Unitary surgical devices (10) are disclosed. One group of the illustrated devices has a pair of biocompatible, bioresorbable anchors (16,18) connected to fixed lengths suture. The anchors (16,18) and fixed length of suture are connected to each other prior to surgery. Another group of unitary surgical devices has a pair of fixating mechanisms (15,17) connected to a base (21) prior to surgery. The second group of illustrated devices generally includes extracellular matrix material either as part of the base (21) or supported on the base (21). The extracellular matrix material serves as tissue regenerating material. In the second group of unitary surgical devices, the fixating mechanisms illustrated generally comprise suture, anchors or pre-formed holes in the base. All of the illustrated unitary surgical devices are useful in repairing a damaged meniscus. The first group of unitary surgical devices can be used to approximate inner surfaces of a tear in the meniscus.

Abstract: The present invention provides compositions including a cell contacting surface or film comprising nanotopography of nanofibers, nanotubes, nanochannels, microchannels or microwells, which are capable of enhancing or promoting cell differentiation or cell viability. The compositions are useful as medical implants, including orthopedic implants, dental implants, cardiovascular implants, neurological implants, neurovascular implants, gastrointestinal implants, muscular implants, and ocular implants. The present invention also provides methods of treating a patient in need of such an implant.

Abstract: Bioabsorbable drug delivery devices including modular drug delivery devices having shapes and sizes adapted to be inserted within a recess on the surface of an implantable prosthesis are disclosed. The devices may be attached to one another to create custom drug delivery devices having controllable drug release characteristics that depend on the composition of individual modules comprising the device. The modules may be cylinders, disks, tiles or tubes comprised of a bioabsorbable polymer and a therapeutic agent. The therapeutic agent(s) may be homogeneously distributed throughout the polymeric body of the device or contained within a cavity within a module comprising the device, or both. The device(s) may be threaded or attached to a prosthesis by a biodegradable adhesive. The modular devices may also be formed into tapered plugs for insertion into a mating receptacle.

Abstract: The present invention involves porous polymer membranes, suitable for use in medical implants, having controlled pore sizes, pore densities and mechanical properties. Methods of manufacturing such porous membranes are described in which a continuous fiber of polymer is extruded through a reciprocating extrusion head and deposited onto a substrate in a predetermined pattern. When cured, the polymeric material forms a stable, porous membrane suitable for a variety of applications, including reducing emboli release during and after stent delivery, and providing a source for release of bioactive substances to a vessel or organ and surrounding tissue.

Abstract: Disclosed herein are methodologies and compositions for coating materials, which can be used in a variety of biological applications.

Abstract: A membrane for implantation in soft tissue comprising a first domain that supports tissue ingrowth, disrupts contractile forces typically found in a foreign body response, encourages vascularity, and interferes with barrier cell layer formation, and a second domain that is resistant to cellular attachment, is impermeable to cells and cell processes, and allows the passage of analytes. The membrane allows for long-term analyte transport in vivo and is suitable for use as a biointerface for implantable analyte sensors, cell transplantation devices, drug delivery devices, and/or electrical signal delivering or measuring devices. The membrane architecture, including cavity size, depth, and interconnectivity, provide long-term robust functionality of the membrane in vivo.

Abstract: Methods and structures are disclosed where carrier fiber is used to enable the assembly of two and three dimensional structures of autologous tissue. Tissue is harvested from the donor, integrated with a carrier fiber, and assembled into complex forms rapidly. The structures can be tailored to the requirements of a specific medical procedure. The tissue is kept live and viable during extracorporeal assembly and the finished structure is emplaced in the donor's body. The use of a carrier fiber leader for pre-threading integration and assembly machines facilitates machine set up, drawing of the tissue into the process, and rapid integration and assembly of the multi-dimensional structures. Assembly can include providing tissue and fiber leaders extending from the structure for attaching the structure in place. The carrier fiber either is bio-absorbed as new tissue forms, or forms a bio-compatible substructure for the patient's native tissue.

Abstract: Magnetic devices and implantation methods are provided for use in the treatment of obstructive sleep apnea. The devices include a sheet-like element having ferromagnetic qualities. The device may also include a permanent magnet attached to the sheet-like element by magnetic forces. The devices are implanted in soft tissue surrounding the airway and in tissue space beneath the pharyngeal wall to exert forces on and/or change the shape of the soft tissue. The magnetic devices may also include a bladder containing a magnetorheological fluid that stiffens soft tissue when exposed to a magnetic field.

Abstract: The present invention provides a ceramic porous body for in-vitro and in-vivo use comprising a composition comprising a calcium aluminate (CA) containing phase and optionally at least one of an accelerator, a retarder, a surfactant, a foaming agent, a reactive alumina, water, a fiber, and a biologically active material, and combinations thereof. Ceramic compositions are provides as well as method of using the ceramic compositions and methods of manufacturing a ceramic porous body. The ceramic porous bodies of this invention may be used as artificial bones, joints, in-vitro support structures, and in-vivo support structures for cells, tissues, organs, and nerve growth and regeneration.

Abstract: The construct described herein allows opposing tissues to form adhesions with either side of the construct, as part of the natural healing process. The construct however is multi-layered, wherein the space between the layers provides the protection from unwanted adhesions forming between and bonding separate tissues. In one embodiment, this space between layers of the construct may be developed spontaneously, that is the multiple layers are released by design after a finite time and the opposing tissues are free to move independent of each other, free of adhesions.

Abstract: Expandable devices and methods for treating and enlarging a tissue, an organ or a cavity. The device is composed of a hollow expanding pouch made of a resorbable material or a perforated material that can be attached to a filling element. The pouch can be filled with a biocompatible materials, one or more times in few days interval, after the insertion of the device. While filling the pouch every few days the tissue expands and the filling material if it is bioactive start to function. The devices allow immediate direct contact between the filling material and the tissue. These devices and methods can be used for example for: horizontal and vertical bone augmentation in the jaws, soft tissue augmentation, fixating bone fractures etc.

Abstract: The invention relates to use of a biological material containing cells supported on three-dimensional scaffolds containing at least one hyaluronic acid derivative for the preparation of grafts suitable for application by arthroscopy, and a kit of surgical instruments for implanting said biological material by arthroscopy.